(28 days)
The Ocelot PIXL System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation as an adjunct to fluoroscopy. The Ocelot PIXL System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
The Ocelot PIXL System consists of the Ocelot PIXL Catheter, the Lightbox Console and the Umbilical. The Ocelot PIXL Catheter is an over-the-wire device that is compatible with a 5F sheath and 0.014" guidewire. The Ocelot PIXL Catheter is available in two different lengths; 135cm working length or 150cm working length and incorporates an optical fiber used to facilitate Optical Coherence Tomography (OCT)-assisted orientation as an adjunct to fluoroscopy.
The provided text is a 510(k) summary for the Avinger Ocelot PIXL Catheter. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in a clinical or human-in-the-loop setting.
The document states that a clinical performance study was not performed. The "Non-Clinical Performance Data" section describes various engineering and bench tests, not studies with acceptance criteria in the sense of accuracy, sensitivity, specificity, or reader performance.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from this document, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are typically associated with clinical or AI-specific performance evaluations which are absent here.
The document states:
- "The following non-clinical testing was previously conducted with the Ocelot PIXL Catheter to support a determination of substantial equivalence to the predicate device." This indicates a focus on engineering verification rather than clinical outcomes or advanced image analysis performance.
- "All data fell well within pre-determined product specifications and external standard requirements." This is the closest the document comes to "acceptance criteria," but these are for engineering specifications (e.g., tensile strength, torque, flexibility) and not performance metrics like accuracy, sensitivity, or reader performance.
In summary, the provided text describes non-clinical testing for substantial equivalence, not a study evaluating performance against acceptance criteria typically seen for diagnostic or AI-assisted devices.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).